a study of xzp-3287 in combination with fulvestrant in patients with advanced breast cancer

Conditions: Advanced Breast Cancer

Summary: this is a phase iii clinical trial to evaluate the efficacy and safety of xzp-3287 in combination with fulvestrant versus placebo combined with fulvestrant in patients who have hr positive and her2 negative recurrent/metastatic breast cancer and have received prior endocrine therapy are eligible for study.


Eligibility criteria:
inclusion criteria: 1. female patients aged ≥18 years and ≤75 years old; 2. patient is in the menopausal state； 3. pathologically-confirmed hr positive and her2 negative breast cancer; 4. locally advanced stage, recurrence or metastasis breast cancer; 4.1 disease progression after previous endocrine therapy； 4.2 one previous line of chemotherapy for advanced/metastatic disease is allowed in addition to endocrine therapy; 5. at least one measurable lesion (based on recist v1.1) or only bone metastases; 6. patient has an eastern cooperative oncology group (ecog) performance status 0 or 1; 7. adequate organ and marrow function; 8. patient of childbearing age must undergo a serum pregnancy test within 14 days before randomization, and the result is negative; patient is willing to use a medically approved high-efficiency contraceptive method during the study period and within 6 months after the last study drug treatment; 9. patient with acute toxic reactions caused by previous anti-tumor treatments or surgical operations were alleviated to grade 0 to 1 (nci-ctcae v5.0), or to the level specified by the enrollment criteria; 10. patient has signed informed consent before any trial related activities. exclusion criteria: 1. patient with visceral crisis, inflammatory breast cancer, or brain metastases, except for patient with stable brain metastases; 2. patient had clinically significant pleural effusions, ascites effusions, or pericardial effusions in the 4 weeks before enrollment; 3. patient who received prior treatment with mtor inhibitors, cdk4/6 inhibitors or fulvestrant; 4. participation in a prior treatment of major surgery, chemotherapy, radiotherapy, and any anti-tumor treatment within 14 days before enrollment； 5. patient who participated in other clinical trials within 14 days before enrollment or within 5 half-lives of the trial drug, whichever is longer; 6. patient used cyp3a4 potent inhibitors or potent inducers within 14 days before enrollment or within 5 half-lives of the drug, whichever is longer; 7. patient who used bisphosphonates or rankl inhibitors within 7 days before enrollment, patient who have started treatment during the study should not change the method of use; 8. any other malignant tumor has been diagnosed within 3 years before randomization; 9. patient is in the active stage of hbv, hcv or co-infected with hbv, hcv, or patient with positive hiv antibody; 10. patient with severe infection within 4 weeks before enrollment, or unexplained fever\> 38.5℃ during screening/before enrollment; 11. patient with heart function impaired or clinically significant heart disease within 6 months before enrollment; 12. cerebrovascular accident occurred within 6 months before enrollment, including history of transient ischemic attack or stroke; symptomatic pulmonary embolism; 13. inability to swallow, intestinal obstruction or other factors that affect the taking and absorption of the drug; 14. patient with a known hypersensitivity to any of the excipients in this study; 15. a prior history of autologous or allogeneic hematopoietic stem cell transplantation; 16. a prior history of psychotropic drug abuse or drug use; 17. pregnant or breastfeeding; 18. the researchers considered that there were some cases that were not suitable for inclusion.

Keywords: xzp-3287 hr positive and her2 negative recurrent/metastatic breast cancer